BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760974 · Received July 13, 2007

    Report

    Report Number
    1823260-2007-06118
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 29, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE VALUES OF 54, 55, 506, & 79 MG/DL WHEN ALL TESTS WERE PERFORMED ONE MINUTE APART ON THE ADVANTAGE SYSTEM. REPORTER STATED, SHE WAS NOT EXPERIENCING ANY HYPERGLYCEMIC OR HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF THE TESTING. NO ACTIONS WERE TAKEN OR TREATMENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549621

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR VITAMINS - 16YRS - ONCE DAILY| ZETIA - 6MOS - 10MG ONCE DAILY| GLUCOPHAGE - 16YRS - 500MG TWICE DAILY| MICRONASE - 16YRS - 5MG TWICE DAILY